guiding principles of pharmacotherapy

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Questions and Answers

What is the primary reason for documenting every medication used?

To justify the use of a medication

When is monotherapy preferred?

When a patient is adequately treated with a single drug

What should be considered when selecting a medication regimen?

Evidence obtained from controlled clinical trials

Why should a medication regimen be simplified?

To enhance patient adherence Signup and view all the answers

What should be observed carefully during treatment?

The patient's response to treatment Signup and view all the answers

When should a medication be given by injection?

When giving it by mouth would be just as effective and safe Signup and view all the answers

What is the primary purpose of the process mentioned in the text?

To protect volunteers from unreasonable risk in clinical trials Signup and view all the answers

What might cause the FDA to place a clinical hold on an IND application?

The volunteers are exposed to unreasonable or significant risk Signup and view all the answers

What is included in a New Drug Application (NDA) submission?

All information from preclinical data to Phase 3 trial data, as well as reports on all studies, data, and analyses Signup and view all the answers

What happens after the FDA receives a New Drug Application (NDA) submission?

The review team decides if the submission is complete Signup and view all the answers

Why might the FDA respond to an IND application with a clinical hold?

Because the materials for the volunteer participants are misleading Signup and view all the answers

What is the purpose of the FDA Review of a New Drug Application?

To demonstrate that a drug is safe and effective for its intended use in the population studied Signup and view all the answers

What is the primary reason for the review team to refuse to file the NDA?

The NDA is incomplete Signup and view all the answers

What is the primary purpose of FDA Advisory Committees?

To provide expert advice on drug approval Signup and view all the answers

What is the hierarchy of evidence in pharmacology, from highest to lowest level?

Systematic Review, Randomized Control Trial, Cohort Studies, Case Control Studies Signup and view all the answers

What is the focus of pharmacokinetics?

The movement of drugs through the body Signup and view all the answers

What is the primary purpose of the FDA's post-market drug safety monitoring?

To identify potential safety risks after a drug is approved Signup and view all the answers

What is the significance of the Patient Representative in FDA Advisory Committees?

To provide input from the patient perspective Signup and view all the answers

What type of kinetics is characterized by a constant amount of drug being metabolized per unit of time?

Zero-order kinetics Signup and view all the answers

Which enzyme is necessary for the conversion of codeine to its active form?

CYP2D6 Signup and view all the answers

What is the primary mechanism of Phase II metabolism reactions?

Conjugation Signup and view all the answers

What is the effect of CYP inducers on drug metabolism?

Increased metabolism and elimination of drug Signup and view all the answers

What is the mechanism by which glomerular filtration affects drug elimination?

Filtered by the glomerulus Signup and view all the answers

What can affect the half-life of a drug?

Diminished renal or hepatic blood flow Signup and view all the answers

What is the primary mechanism of absorption of most drugs from the GI tract?

Passive diffusion Signup and view all the answers

What is the main difference between facilitated diffusion and active transport?

Energy dependence Signup and view all the answers

What is the role of P-glycoprotein in drug absorption?

Inhibits absorption Signup and view all the answers

What is the name of the law that describes the passive movement of molecules down its concentration gradient?

Fick's Law Signup and view all the answers

What is the term for the process by which a drug is absorbed from the GI tract and then removed by the liver before it reaches the systemic circulation?

First pass effect Signup and view all the answers

What is the term for the ability of a drug to be dissolved in a solvent?

Solubility Signup and view all the answers

The FDA has ______ to 10 months to make a decision on whether to approve the drug.

6 Signup and view all the answers

Pharmacokinetics is the study of the movement of ______ through the body.

drugs Signup and view all the answers

When making a decision about drug therapy for individual patients, ______ effects should be considered.

societal Signup and view all the answers

The Drug Development Process involves the examination of Molecular Compounds of how it is ______, distributed, metabolized, and excreted.

absorbed Signup and view all the answers

The best way to give the drug can be by ______ or injection.

mouth Signup and view all the answers

Two drug formulations that show comparable ______ and similar times to achieve peak blood concentrations are bioequivalent.

bioavailability Signup and view all the answers

Any factor that increases Volume of Distribution can increase the ______ and extend the duration of action of the drug.

half-life Signup and view all the answers

A drug reaches steady state in approximately ______ half-lives.

5 Signup and view all the answers

In first-order kinetics, a constant ______ of drug is metabolized per unit of time.

fraction Signup and view all the answers

In zero-order kinetics, a constant ______ of drug is metabolized per unit of time.

amount Signup and view all the answers

What is the primary mechanism of movement of hydrophilic drugs across the cell membrane?

Aqueous diffusion Signup and view all the answers

What is the term for the movement of molecules through water or oil?

Diffusion Signup and view all the answers

What is the role of the phospholipid bilayer in the cell membrane?

To form a barrier to diffusion Signup and view all the answers

What determines the percentage of a drug that is hydrophobic (lipid soluble) in the small bowel?

pH of the small bowel Signup and view all the answers

What is the name of the law that describes the passive movement of molecules down its concentration gradient?

Fick's Law Signup and view all the answers

What is the term for the process by which a drug is absorbed from the GI tract and then removed by the liver before it reaches the systemic circulation?

First-pass effect Signup and view all the answers

What is the amount of compound C ingested by a 25-year-old, given a concentration of 300 ng/ml and a Vd of 100 l?

30 mg Signup and view all the answers

A patient has a resistant septic infection with a bacteria highly sensitive to Vancomycin. If the patient weighs 73 kg and the Vd of vancomycin is 0.7 l/kg, how much drug should be given to achieve a concentration of 20 µg/ml?

1 g Signup and view all the answers

What is the next phase of drug development for Gargantua Pharmaceuticals' eyedrop that can give humans X-ray vision?

Phase 2 Signup and view all the answers

What is the formula to calculate the volume of distribution (Vd)?

Vd = amount/concentration Signup and view all the answers

What is the unit of measurement for the volume of distribution (Vd) in Case Study 2?

l Signup and view all the answers

What is the mathematical relationship between the dissociation constants pKa and pKb?

pKa + pKb = 14 Signup and view all the answers

What is the ionization constant at equilibrium for a weakly basic drug B?

Kb = ([BH+] [OH-]) / [B] Signup and view all the answers

What is the concentration of compound C in Case Study 2?

300 ng/ml Signup and view all the answers

What is the equation for the proportions of a weak base in non-ionized and ionized forms at any pH?

log [B]/[BH+] = pH - pKa Signup and view all the answers

What is the effect of protonation on the solubility of a weak base?

Protonation increases solubility Signup and view all the answers

What is the relationship between pH and the proportion of non-ionized to ionized forms of a weak base?

As pH increases, the proportion of non-ionized forms increases Signup and view all the answers

What is the primary purpose of knowing the pKa of a drug?

To enhance excretion of a toxin and design drugs Signup and view all the answers

What is the term for the logarithm of the acid dissociation constant Ka?

pKa Signup and view all the answers

What percentage of the drug will be hydrophobic in the small bowel at a pH of 4.8, given a pKa of 3.8?

10% Signup and view all the answers

What is the relevance of knowing the pKa of a drug in case of an overdose?

It helps in enhancing excretion of the toxin Signup and view all the answers

What happens to the ratio of ionized to non-ionized forms of a drug when the pH increases by 1 unit above the pKa?

The ratio changes from 1:1 to 1:10 Signup and view all the answers

What is the significance of the pKa of a drug in the small bowel?

It determines the percentage of the drug that is hydrophobic Signup and view all the answers

Why is it important to consider the pKa of a drug when designing drugs?

To enhance excretion of a toxin and design drugs Signup and view all the answers

What is the primary goal of Phase 1 clinical trials?

To evaluate the safety and dose-response relationship in healthy volunteers Signup and view all the answers

What is the category of a drug that has positive evidence of human risk and is only used in life-threatening situations?

Category X Signup and view all the answers

What is the purpose of Phase 4 clinical trials?

To conduct postmarketing surveillance and monitor the drug's safety Signup and view all the answers

What is the purpose of preclinical testing?

To identify the drug's chemical parameters and conduct environmental testing Signup and view all the answers

What is the category of a drug that has no evidence of fetal risk in animals, but no controlled studies in women?

Category B Signup and view all the answers

What is the purpose of Phase 2 clinical trials?

To identify the pharmacokinetics and pharmacodynamic data of the drug Signup and view all the answers

What is the primary purpose of the PREP Act?

To provide liability protection for medical professionals Signup and view all the answers

Under what circumstances does the PREP Act provide immunity from liability?

For those who administer authorized countermeasures Signup and view all the answers

Why did the patient's son refuse to consent to the administration of hydroxychloroquine?

Because of the patient's history of heart issues Signup and view all the answers

What was the outcome of the patient's administration of hydroxychloroquine without consent?

The patient's condition deteriorated and she died Signup and view all the answers

What action did the patient's family take after the patient's death?

They sued the senior living facility Signup and view all the answers

What can be inferred from the case about the PREP Act immunity?

It only applies to authorized countermeasures Signup and view all the answers

What was the basis of the defendant facility's motion to dismiss the case?

PREP Act immunity Signup and view all the answers

What was the condition for using hydroxychloroquine under the March 28 EUA?

Treating adult and adolescent patients weighing 50 kg or more Signup and view all the answers

Why did the court find that the defendant facility's PREP Act immunity argument was invalid?

The patient was not hospitalized Signup and view all the answers

What was the plaintiffs' argument against the defendant facility's PREP Act immunity claim?

The patient did not meet the EUA's conditions Signup and view all the answers

What was the significance of the FDA's emergency use authorization (EUA) in this case?

It authorized the use of hydroxychloroquine under certain conditions Signup and view all the answers

What was the outcome of the defendant facility's motion to dismiss the case?

The motion was denied Signup and view all the answers

What is the primary reason for the court's ruling on the defendant's motion to dismiss?

The defendants' administration of hydroxychloroquine sulfate was not explicitly authorized by the FDA. Signup and view all the answers

What is the significance of an EUA according to the text?

It specifies the guidelines and limitations for the use of a drug. Signup and view all the answers

What is the significance of the PREP Act according to the text?

It provides immunity for the use of a drug only under certain circumstances. Signup and view all the answers

What was the outcome of the defendant's motion to dismiss?

The motion was denied. Signup and view all the answers

What happened to the hydroxychloroquine EUA after the patient's death?

It was revoked six weeks after the patient's death. Signup and view all the answers

What is the main lesson learned from this case, as stated in the text?

Improvements can be made to the way things were done in the past. Signup and view all the answers

What is the primary driving force for passive diffusion of a drug?

Concentration gradient Signup and view all the answers

Which type of diffusion does not require energy and can be saturated?

Facilitated diffusion Signup and view all the answers

What is the characteristic of lipid-soluble drugs in terms of their ability to penetrate cell membranes?

They can only penetrate through lipid bilayers Signup and view all the answers

What is the difference between facilitated diffusion and active transport?

Facilitated diffusion is not energy-dependent, while active transport is Signup and view all the answers

What is the primary function of carrier proteins in facilitated diffusion?

To facilitate the passage of large molecules Signup and view all the answers

What is the characteristic of water-soluble drugs in terms of their ability to penetrate cell membranes?

They penetrate the cell membrane through aqueous channels or pores Signup and view all the answers

Study Notes

Mechanisms of Absorption in the GI tract

Passive diffusion: the driving force is the concentration gradient, moving from high to low concentration, and does not involve a carrier, is not saturable, and shows low structural specificity.
Most drugs are absorbed by passive diffusion.
Water-soluble drugs penetrate the cell membrane through aqueous channels or pores.
Lipid-soluble drugs move across biologic membranes due to solubility in membrane lipid bilayers.

Facilitated Diffusion

Involves specialized transmembrane carrier proteins that facilitate the passage of large molecules.
Undergoes conformational changes, allowing the passage of drugs or endogenous molecules into the interior of cells.
Does not require energy, can be saturated, and may be inhibited by compounds that compete for the carrier.

Active Transport

Involves specific carrier proteins that span the membrane.
Energy dependent, driven by the hydrolysis of adenosine triphosphate (ATP).
Capable of moving drugs against a concentration gradient, from low to high concentration.
The process is saturable and selective.
May be competitively inhibited by other cotransported substances.

Endocytosis

Used to transport exceptionally large drugs across the cell membrane.
Involves engulfment of a drug by the cell membrane and transport into the cell by pinching off the drug-filled vesicle.
Example: Vitamin B12 is transported across the gut wall by endocytosis.

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